Actively Recruiting
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
Led by Otsuka Pharmaceutical Factory, Inc. · Updated on 2026-03-02
13
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.
CONDITIONS
Official Title
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 35 and 65 years at consent
- Diagnosed with Type 1 Diabetes Mellitus for at least 5 years
- Unstable T1DM despite treatment with a closed loop system (specific insulin pumps and CGMs) for at least 6 months
- Experienced at least three Level 3 (severe) hypoglycemic episodes within the past year or one episode with Clarke Score 4 or TBR >1% with Clarke Score 4
- C-peptide level <0.3 ng/mL after mixed meal tolerance test or undetectable fasting C-peptide
- Hemoglobin A1C (HbA1c) 4 9.0
- Use of contraception consistent with local regulations
- Willing to cooperate with lifetime follow-up after transplantation
- Capable of providing signed informed consent
You will not qualify if you...
- History of insulin resistance requiring 5 0.8 unit/kg/day insulin dose for 1 week prior to enrollment
- Diagnosis of LADA, ketosis-prone diabetes, or MODY
- C-reactive protein (CRP) 5 10 mg/L
- Clinically unstable thyroid disease or abnormal TSH levels outside normal range
- History of malignancies in past 5 years except basal or squamous cell carcinoma
- Positive tests for HIV, hepatitis B or C
- Active or untreated proliferative diabetic retinopathy
- Serious comorbid conditions affecting participation including recent peripheral vascular disease with amputation, heart failure NYHA class II-IV, chronic lung diseases with hospitalization or corticosteroid use, macroalbuminuria >300 mg/g creatinine, or eGFR <30 ml/min
- Use of warfarin or other anticoagulants except aspirin, or PT-INR >1.5
- Adrenal insufficiency treated with corticosteroids
- Previous pan-peritonitis
- Previous cardiovascular or cerebrovascular disease including recent myocardial infarction, non-correctable coronary artery disease, ischemia on cardiac exam, or heart failure NYHA class >II
- Hematopoietic stem cell abnormalities
- Recent blood transfusion or anticipated surgery requiring transfusion
- Previous organ, skin allograft, or tissue transplant from human or animal donor
- Treatment with immunosuppressive medications
- Previous abdominal surgery except certain minor surgeries more than 12 weeks prior
- Use of hypoglycemic medications other than insulin
- Treatment with acetaminophen or hydroxycarbamide
- Use of investigational products within 12 weeks before enrollment
- History of allergy to antibiotics used in OPF-310 manufacture
- History of allergy to insulin, pork products, or alginate/seaweed
- Panel reactive antibodies (PRA) >80%
- Active drug, substance, or alcohol addiction
- Body mass index (BMI) >27 kg/m2
- Any condition that may interfere with protocol adherence including dementia, psychiatric disorder, or history of non-adherence
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
F
For participant-focused inquiries, please contact:
CONTACT
F
For physician or professional inquiries, please contact:
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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